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Table 3 Summary of mean plasma pharmacokinetic parametersa

From: A 28-day, randomized, double-blind, placebo-controlled, parallel group study of nebulized revefenacin in patients with chronic obstructive pulmonary disease

Dose (μg) Cmax (ng/mL) tmax (hr) AUC0-24 (nghr./mL) AUC0–t (nghr./mL) t1/2 (hr)
44 0.0203 ± 0.0124 0.483 (0.350, 0.500) 0.0347 ± 0.0106 0.0299 ± 0.0098 NCb
n 7 7 4 4 1
88 0.0282 ± 0.0157 0.500 (0.417, 12.3c) 0.155 ± 0.0749 0.129 ± 0.0589 NC
n 9 9 6 6 0
175 0.121 ± 0.157 0.517 (0.467, 0.767) 0.351 ± 0.364 0.720 ± 0.864 51.9 ± 31.5
n 9 9 9 9 5
350 0.146 ± 0.148 0.500 (0.433, 0.583) 0.365 ± 0.306 0.724 ± 0.833 57.9 ± 31.5
n 8 8 8 8 7
  1. aData are mean ± SD except for tmax data which are median (minimum, maximum)
  2. bT1/2 values were not calculated for the majority of subjects at revefenacin 44 and 88 μg due to limited data at these dose levels
  3. cThe concentration observed at this tmax value was considered to be high compared to the rest of the subject’s profile and was reanalyzed. Reanalysis confirmed the original result, and the value was included in PK analysis
  4. Abbreviations: AUC 0–24 area under the curve for plasma concentration-time from time 0 to 24 h, AUC 0–t area under the curve for plasma concentration-time from time 0 to the last detectable time point, C max maximum plasma concentration, hr. hours, NC not calculated, PK pharmacokinetics, SD standard deviation, t 1/2 terminal elimination half-life, t max time to maximum plasma concentration